摘要
Objective:To evaluate the effects of Chinese medicine Dingkun Pill(定坤丹)alone or in combination with Diane-35 on patients with polycystic ovary syndrome(PCOS).Methods:This is a prospective randomized controlled trial conducted at Peking Union Medical College Hospital Beijing,China,from December 2016 to September 2017.Totally 117 PCOS patients were randomly assigned to the Dingkun Pill group(38 cases),Diane-35 group(40 cases),or combined group(39 cases).Patients in the Dingkun Pill group or Diane-35 group took daily 7 g of oral Dingkun Pill or 1 tablet of oral Diane-35,respectively,for 21 consecutive days followed by 7 drug-free days.And the combined group received a combination of Dingkun Pill and Diane-35.The treatment course was 3 months.Fasting plasma glucose and insulin,total cholesterol(TC),low-density lipoprotein cholesterol(LDL-C),triglycerides(TG),free fatty acids(FFA)and sex hormones were analyzed,quantitative insulin sensitivity check index(QUICKI)was calculated,and menstruation and acne scores were recorded at baseline and after 3-month treatment.Results:Compared with before treatment,QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment(P<0.05);TC,LDL-C and FFA decreased significantly in the Dingkun Pill group(P<0.01),LDL-C also decreased obviously in the Diane-35 group(P<0.01),while TC increased significantly in the combined group(P<0.01),TG increased significantly in all groups(P<0.01);total testosterone(TT)and menstruation regularity was improved significantly in the Diane-35 and combined groups(P<0.01);acne scores were improved in all groups(P<0.01).After treatment,TC and FFA in the Dingkun Pill group were significantly lower than the Diane-35 group(P<0.05 or P<0.01);TT was lower and regular menstruation rate was higher in the Diane-35 and combined groups than the Dingkun Pill group(P<0.01),and no differences were observed between Diane-35 group and combined group(P>0.05).Conclusions:Dingkun Pill showed better effects than Diane-35 in improving insulin sensitivity,lowering TC and FFA.Diane-35 was more efficient in regulating menstruation and lowering androgen than Dingkun Pill.Combination of Dingkun Pill and Diane-35 may be a better choice to regulate menstruation,lower androgens while improve glucose metabolism in PCOS patients.(Registered on ClinicalTrials.gov,registration No.NCT03264638)。
